Wound Management Tray II recall: Sterility Concern
Wound Management Tray II, Catalog number 900-1198. Used by medical staff to perform patient care procedures such as wound healing, suture removals…
Why was Wound Management Tray II recalled?
Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot numbers: 111112987 112010275 112030830 112041392 112051737 112062338 112072827 112093746 113015492 113026217 113047317 113068142 113109711 140111111 140312056 140513037 140714161 140915150
- Product
- Wound Management Tray II, Catalog number 900-1198. Used by medical staff to perform patient care procedures such as wound healing, suture removals…
- Recalling firm
- Customed, Inc
- Quantity
- 28020
- Distribution
- US Distribution to Florida, New York and Puerto Rico..
- Recall date
- December 10, 2014
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (device)